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NCT02647086 · ClinicalTrials.gov registry record · Phase 1
Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)
A Phase 1 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02647086 is a Phase 1 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 14 participants.
The verdict
NCT02647086, a Phase 1 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is an open-label, single-sequence DDI study designed to examine the effects of dupilumab on the pharmacokinetics of selected cytochrome P450 substrates in adult patients with moderate to severe AD. The study consists of a screening period (day -35 to -2), study period 1 (day -1 to 7), study period 2 (day 8 to 50), and a follow-up period (day 51 to 135 \[end of study\]). Following completion of study period 2 (Day 50), patients will be given the option to enroll into the Open-Label Extension (OLE) study R668-AD-1225. Patients who decline will be followed for the next 12 weeks (Day 135).
Interventions
- DRUG Dupilumab
- DRUG Midazolam
- DRUG Omeprazole
- DRUG Caffeine
- DRUG Warfarin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02647086
The ClinicalTrials.gov registry entry for NCT02647086 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dupilumab is the first listed.
NCT02647086 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02647086 about?
NCT02647086 is a clinical study titled "Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)". This is an open-label, single-sequence DDI study designed to examine the effects of dupilumab on the pharmacokinetics of selected cytochrome P450 substrates in adult patients with moderate to severe AD. The study consists of a screening period (day -35 to -2), study period 1 (day -1 to 7), study pe...
What is the current status of trial NCT02647086?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2015-12. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02647086?
The interventions under investigation include: Dupilumab (DRUG), Midazolam (DRUG), Omeprazole (DRUG), Caffeine (DRUG), Warfarin (DRUG).
Who is sponsoring clinical trial NCT02647086?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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